Persona Total Knee Arthroplasty Outcomes Study

August 27, 2023 updated by: Zimmer Biomet

Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Study Type

Interventional

Enrollment (Actual)

737

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Joint Replacement
      • Fort Collins, Colorado, United States, 80525
        • Orthopaedic & Spine Center of the Rockies
      • Parker, Colorado, United States, 80134
        • Denver-Vail Orthopedics
    • Illinois
      • Rockford, Illinois, United States, 61114
        • Rockford Orthopedic Associates
    • Indiana
      • New Castle, Indiana, United States, 47362
        • Henry County Orthopedics and Sports Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7055
        • UNC Department of Orthopaedics
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina
      • Raleigh, North Carolina, United States, 27612
        • Raleigh Orthopaedic Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Lindner Research Center
      • Columbus, Ohio, United States, 43215
        • SportsMedicine Grant & Orthopaedic Associates
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Knoxville, Tennessee, United States, 37930
        • Tennessee Orthopaedic Foundation for Education and Research
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23462-1784
        • Jordan Young Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient 18-75 years of age, inclusive
  • Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
  • Patient has participated in a study-related Informed Consent process
  • Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
  • Patient is willing and able to complete scheduled study procedures and follow-up evaluations
  • Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling

Exclusion Criteria:

  • Patient is currently participating in any other surgical intervention studies or pain management studies
  • Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
  • Insufficient bone stock on femoral or tibial surfaces
  • Skeletal immaturity
  • Neuropathic arthropathy
  • Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
  • Stable, painless arthrodesis in a satisfactory functional position
  • Severe instability secondary to the absence of collateral ligament integrity
  • Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
  • Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
  • Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
  • Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PERSONA TKA
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Device: Zimmer Persona Total Knee System
Primary Total Knee Arthroplasty
Other Names:
  • Total Knee Replacement
  • Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: 10 years
Knee Society Score
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D
Time Frame: 10 years
EQ-5D
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Kacy Arnold, RN, MBA, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimated)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU2014-02K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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